510(k) · Cleared
ClearedApplicators for Varian Varisource Remote High Dose Rate Afterloader
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Assoc., Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Jul 26, 1996 as substantially equivalent to K901615 (Omnitron Intl., Inc., 1992) and 2 other predicates after a 213-day review. Its family tree reaches back 1 generation to 1992. 4 later devices descend from it.
- Decided
- Jul 26, 1996
- Review
- 213 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K913908 (1992). 3 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK913908 Omnitron Gyn Applicator SystemOmnitron Intl., Inc. · 1992
- This deviceK955844 Applicators for Varian Varisource Remote High Dose Rate AfterloaderVarian Assoc., Inc. · 1996
- Descendant · cites it directly · 1 of its ownK063381 CT Compatible F/S/D ApplicatorsMick Radio-Nuclear Instruments, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK200221 CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem…Mick Radio-Nuclear Instruments, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK172675 Varian Cervical SleevesVarian Medical Systems, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK033828 CT Compatible Intrauterine Sleeves, Cat #0311, 9406Mick Radio-Nuclear Instruments, Inc. · 2004
Most influential descendants
Showing 4 of 4 · See all- K063381CT Compatible F/S/D ApplicatorsMick Radio-Nuclear Instruments, Inc. · 2006 · cites it directly1descendant
- K200221CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators…Mick Radio-Nuclear Instruments, Inc. · 2020 · 2 generations on0descendants
- K172675Varian Cervical SleevesVarian Medical Systems, Inc. · 2018 · cites it directly0descendants
- K033828CT Compatible Intrauterine Sleeves, Cat #0311, 9406Mick Radio-Nuclear Instruments, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913908 | Omnitron Gyn Applicator System | Omnitron Intl., Inc. | 1992 | — |
| 0 (this device) | K955844 | Applicators for Varian Varisource Remote High Dose Rate Afterloader | Varian Assoc., Inc. | 1996 | — |
| +1 | K063381 | CT Compatible F/S/D Applicators | Mick Radio-Nuclear Instruments, Inc. | 2006 | — |
| +2 | K200221 | CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid… | Mick Radio-Nuclear Instruments, Inc. | 2020 | — |
| +1 | K172675 | Varian Cervical Sleeves | Varian Medical Systems, Inc. | 2018 | — |
| +1 | K033828 | CT Compatible Intrauterine Sleeves, Cat #0311, 9406 | Mick Radio-Nuclear Instruments, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JAQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JAQ device
- #1 K241853 Titanium Fletcher-Style Applicator Set Defined…score 14.9 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K901615 | Pulmocath Intrabronchial CatheterSummary page 1…15) 424-5036 FAX: (415) 424-4830 Prepared: = December 20, 1995 Applicators and Accessories for Varian VariSource Remote High Dose Rate Afterloader Omnitron PulmoCath K901615/F Cleared on November 27, 1992 Omnitron GYN Applicator System K913908/B Cleared on March 6, 1992 Applicators for Varian VariSou… | 1992 |
| * | K913908 | Omnitron Gyn Applicator SystemSummary page 1…cators and Accessories for Varian VariSource Remote High Dose Rate Afterloader Omnitron PulmoCath K901615/F Cleared on November 27, 1992 Omnitron GYN Applicator System K913908/B Cleared on March 6, 1992 Applicators for Varian VariSource Remote High Dose Rate Afterloader K952913 Cleared on November 22,… | 1992 |
| * | K952913 | Applicators for Varian Varisource Remote High Soes Rate AfterloaderSummary page 1…5/F Cleared on November 27, 1992 Omnitron GYN Applicator System K913908/B Cleared on March 6, 1992 Applicators for Varian VariSource Remote High Dose Rate Afterloader K952913 Cleared on November 22, 1995 The applicators for the Varian VariSource Remote High Dose Rate Afterloader are part of a remote c… | 1995 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- Of its descendants, K063381 (Mick Radio-Nuclear Instruments, Inc., 2006) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JAQ devicesJAQ System, Applicator, Radionuclide, Remote-Controlled: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAQ
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAQ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAQ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAQ
3in 2025
MAUDE reports naming product code JAQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 48 | 0 | 13 |
| 2008 | 10 | 34 | 5 | 32 |
| 2009 | 10 | 27 | 1 | 35 |
| 2010 | 2 | — | 2 | 36 |
| 2011 | 2 | — | 13 | 42 |
| 2012 | 7 | 89 | 5 | 34 |
| 2013 | 6 | 100 | 1 | 43 |
| 2014 | 7 | 116 | 0 | 18 |
| 2015 | 11 | 183 | 0 | 7 |
| 2016 | 6 | 154 | 0 | 3 |
| 2017 | 7 | 229 | 0 | 5 |
| 2018 | 7 | 252 | 0 | 2 |
| 2019 | 2 | — | 1 | 8 |
| 2020 | 4 | 62 | 0 | 8 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 2 | — | 0 | 3 |
| 2024 | 10 | 126 | 0 | 1 |
| 2025 | 6 | 91 | 0 | 3 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The Varian VariSource Remote High Dose Rate Afterloader system, including the applicators included in this notification, is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy with a high specific activity radioisotope source to reduce the exposure times required to achieve a prescribed dose. Remote operation of the Afterloader eliminates the necessity of exposing medical personnel to…
Read the full statement (158 words)
The Varian VariSource Remote High Dose Rate Afterloader system, including the applicators included in this notification, is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy with a high specific activity radioisotope source to reduce the exposure times required to achieve a prescribed dose. Remote operation of the Afterloader eliminates the necessity of exposing medical personnel to radiation during hand loading or hand placement of radioactive sources on or within the body of a patient. The radioactive source is iridium-192, encapsulated in the end of a wire stored in the Afterloader and mechanically driven from it to a precisely described position for a specified dwell time during treatment. Between treatments the wire is retracted into the Afterloader and the source resides in a tungsten-shielded safe to limit personnel exposures to an acceptable, safe level. The Afterloader contains a radiation detector which signals whenever the source is not in the safe.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K955844 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955844: Applicators for Varian Varisource Remote High Dose Rate Afterloader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955844
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026